Proceedings of the PSM Workshop - Nairobi 2-9 Dec. 2004The impacts of Quality Assurance on the PSM...

Proceedings of the Procurement and Supply Management

Plan Workshop Nairobi, 2-9 December 2004

PSM Workshop Report 1st Draft of 64

Table of Contents

ABBREVIATIONS............................................................................................................ 5

ACKNOWLEDGEMENTS.......................................................................................... 6

SUMMARY............................................................................................................................ 7

DAY ONE: DECEMBER 2, 2004 ...................................................................... 13

SYNOPSIS .................................................................................................................................... 13 HIGHLIGHTS OF THE PRESENTATIONS............................................................................................ 13

1. Objectives of the PSM Workshop: Dr. Jos Perriens, WHO ..................................... 13 2. Briefing on Workshop Proceedings: Dr. Vincent Habiyambere, WHO................... 13 3. The Procurement and Supply Management Plan: A Key Step Towards the Implementation of Global Fund Grants: Dr. Ben Eiichi Seki, GFATM .............................. 14

ADDITIONAL COMMENTS ........................................................................................................... 15 4. Overview of the Procurement Cycle: Product Selection: Ethel Capuno, UNDP ..... 15 5. HIV Medicines Selection: Experience from Uganda: Joseph Serutoke, Essential Drugs and Medicines Policy, WHO/Uganda .................................................................... 16

GROUP WORK PRESENTATIONS ................................................................................................. 18 Group Presentation 1: Feedback on Key Issues on Product Selection ............................. 18 Group Presentation 2: Feedback on Implementation of Key Components....................... 18 Group Presentation 3: Feedback on Technical Assistance necessary to implement PSM Plans 19 Discussion on Group Presentations .................................................................................. 19

DAY TWO: DECEMBER 3, 2004 ...................................................................... 21


6. Technical Overview of the PSM Plan: Paul Lalvani, GFATM ................................... 21 7. Forecasting – Estimating Needs: Helen Möller, UNICEF........................................... 22 8. Intellectual Property in Medicine Procurement: Patrick Osewe, World Bank ......... 23

HIGHLIGHTS OF GROUP PRESENTATIONS ................................................................................... 24 Group Presentation 1: Feedback on Issues to cover in PSM Plans................................ 24 Group Presentation 2: Feedback on Issues Around Implementation............................. 24 Presentation 3: Feedback on Technical assistance Needs for Implementation.............. 25 Discussion on Group Presentations .................................................................................. 25

DAY THREE: DECEMBER 4, 2004................................................................. 27


9. Storage, LMIS, Inventory Management and distribution: Augustine Bahati, Jayne. Waweru, Steve Kinzett (John Snow Inc.?) ....................................................................... 27

HIGHLIGHTS OF GROUP PRESENTATIONS....................................................................................... 30 Group Presentation 1: Issues to cover in PSM plan....................................................... 30 Group Presentation 2: Feedback on Issues Around Implementation............................. 30


Discussion on Group Presentations .................................................................................. 31 Group Presentation 3: Technical Assistance Needs for Implementation....................... 34

DAY FOUR: DECEMBER 6, 2004..................................................................... 35

SYNOPSIS: .................................................................................................................................. 35 HIGHLIGHTS OF THE PRESENTATIONS ........................................................................................ 35

10. Quality Assurance: Thomas Lapnet-Moustapha (WHO/AFRO).......................... 35 11. Procurement of non-heath items: Ethel Capuno (UNDP, Manila) ....................... 36 12. Patent Situation of HIV/AIDS-related drugs in 80 countries: Jos Perriens (WHO/HQ) ....................................................................................................................... 37 13. Intellectual Property Rights in Medicines Procurement: Patrick Osewe (World Bank) 38

HIGHLIGHTS OF GROUP WORK PRESENTATIONS ............................................................................ 40 Group Presentation 1: Feedback on the PSM Plan ....................................................... 40 Group Presentation 2: Feedback on Issues around implementation of QA and procurement of non-health products ................................................................................. 40 Group Presentation 3: Feedback on needs for technical assistance for QA ................. 40 Discussions on Group Work Presentations:...................................................................... 40

DAY FIVE: DECEMBER 7, 2004 ...................................................................... 43


14. Rational Drug Use: Prescribing, Dispensing, Counseling and Adherence in ART Programs: Bannet Ndyanabangi (MSH/RPM Plus).......................................................... 43 15. Standard Operating Procedures for Pharmaceutical ART Services: Jedida Wachira (RPM Plus)........................................................................................................................ 44 16. Standard Operating Procedures for Laboratory ART Services: Ephantus Njagi.. 44 17. Management Information Systems: Sergio Valdini (UNDP, Liberia).................. 46 18. Procurement and Supply Chain Management Consortium: Addressing Implementation and Capacity Building simultaneously: Crown Agents, GTZ and JSI Logistic Services............................................................................................................... 47

HIGHLIGHTS OF THE GROUP WORK PRESENTATIONS:................................................................ 48 Group Presentation 1: Feedback on the PSM Plan ...................................................... 48 Group Presentation 2: Feedback on Implementation Issues To Be Covered................ 49 Group Presentation 3: Feedback on Implementation of RDU...................................... 49

DAY SIX: DECEMBER 8, 2004 .......................................................................... 51


19 HIV/AIDS Related Procurement: Management Capacity and Financing: Nadeem Mohammed (World Bank)................................................................................................ 51 20. HIV/AIDS Commodities Tracking Tool: Laila Akhilagi (RPM Plus) ................. 53 21. The Global Fund Template (newest version): Paul Lalvani (Global Fund) ......... 54 22. TA Requests: Tomas Schick (UNAIDS) .............................................................. 54 23. Outcomes of the Workshop: Paul Lalvani (Global Fund) .................................... 55


24 Closing Remarks: Dr. Vincent Habiyambere (WHO/HQ) with inputs from Dr. Jos Perriens (WHO) and Dr. Patrick Osewe (World Bank).................................................... 56

IN CONCLUDING, THE SPEAKERS REITERATED THAT: ................................................................. 56

DAY SEVEN: DECEMBER 9, 2004.................................................................. 57

SITE VISITS BY PARTICIPANTS AND FACILITATORS................................................... 57 ANNEXES................................................................................................................................ 58

Annex 1 Time table for Daily Proceedings ................................................................. 58 Annex 2 List of Participants ........................................................................................ 64


Abbreviations


Acknowledgements

This workshop preparation and organization was made possible by the joint effort involving several partners, namely: United Nations Agencies:

• WHO EDM/AFRO EDM /HQ HIV/AFRO CPS/HQ HIV Department WHO Representatives of the 13 participating countries

• The UNAIDS Secretariat • UNICEF • The World Bank • UNDP

Partner Organizations

The Global Fund Secretariat and Recipients of the 13 participating countries • • USAID • The Gates Foundation • Clinton HIV/AIDS Initiative • JSI • MSH • MSF • EPN • CEDMAP • IDA • ESTHER • Crown Agents • MSF

The funding, identification of the participants, organizing, planning and travel arrangements for this workshop were undertaken by WHO and GFATM. Their own governments designated participants of countries. The WHO Representative Office in Kenya hosted the workshop and provided the logistical support before, during and after the workshop.


SUMMARY

Objectives of the Workshop: The workshop aimed to:

Assist African countries with approved GFATM proposals in the development of their PSM plans so that they are able to submit to the GFATM by the end of 2004

Assist countries with draft PSM Plans in developing the work plan for technical assistance required to strengthen their national PSM system

In the process, the workshop aimed to also:

Strengthen collaboration between AMDS partners at country, regional and global levels Identify expertise required for further technical support to participating countries in

strengthening their national PSM system, including the finalization of the PSM plan 1. The Key issues that evolved in the workshop are:

• The status of the Global Fund grants and the processes of grant approval, with emphasis on the Procurement and Supply Management Plan. As countries roll out funding mechanisms, the biggest challenge is to know about grants management, which requires great capacity building

• Procurement was defined in its strategic role in the success or failure of an ARV treatment program. The importance of product selection as a vital link in the wide network of factors affecting the success or failure of the battle against HIV/AIDS and the delivery of health care in general was highlighted.

The impacts of Quality Assurance on the PSM cycle were discussed, viz. Selection, Quantification, Procurement, Management, Distribution, and Utilization. The issues of bio-equivalence of ARVs, de-listing and handling of defective supplies were also discussed. The position of the Global Fund with regard to the procurement of medicines that were approved by the recipient country, but not pre-qualified by the WHO was discussed. The matter will be tabled again at the next GF board meeting in April 2005.

Key steps in procurement were revisited with accentuation of needed emphasis: (for product selection, forecasting, procurement, warehousing, inventory management, transportation, and serving clients.

Causes of delays were outlined for each step. These include the lack of clinical protocols, guidelines, policies, data (on consumption patterns or stock levels), poor specifications, incomplete projections, unclear procedures, breaks in information to storage staff of impending procurement, volume deficiencies, lack of essential computerizations and stock cards, unclear transport procedures, and lack of availability of commodities, and insufficient budget allocations

The challenges and options for countries in accessing funds for Technical Assistance before the Global Funds are disbursed was raised. A twinning arrangement for TA was suggested as a possibility and will be considered by GFATM.

The essential data items for LMIS: viz. stock at hand, rates of consumption and losses and adjustments were introduced and discussed.


The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS Agreement”), its various “transitional arrangements” in favor of “developing” and “least developed” members, The Doha Declaration, and issues of ARIPO agreements emerged as a burning issue. Some multinationals that have agreed to differential pricing for ARVs were not seen as being committed to supplying.

• Rational ARV drug use was highlighted as being critical for program success in the Pharmaceutical management cycle. The consequences of irrational medicine use are poor health outcomes and increased health care costs.

The concepts, processes and benefits of SOPs for Pharmaceutical and Laboratory ART services were outlined to include: ensuring quality and consistency of services, clarification of roles, a training tools, a means for delegation, and the provision of standards for monitoring and supervision.

The MIS system from UNDP Liberia was introduced, as a tool to support the M&E unit in terms of reporting needs, efficient tracking systems, and graphical presentation of information for Strategic Management. The background of the MSH Commodities Tracking Tool was described, as originating from a July 2003 meeting of MSH, Global Fund, World Bank and the U.S. Government which had the objectives of identifying HIV/AIDS commodities management issues of concern to key global partners.

The goals and methodology of the KEMSA (consortium) were introduced as a case study in a three-phase approach consisting of: Phase 1(Immediate Response), Phase 2 (Intensive Capacity Building), & Phase 3 (Sustainable Delivery by KEMSA).

Issues of coordination were discussed: How to mix funding streams in situations of multi-donor funding, and to organize the accounting for products from different sources especially with the set of different products and treatment regimens using different sources of funding.

Public/private sector collaboration on ART, including FBOs and NGOs were discussed.

2. Identified challenges to PSM include:

• Programme Policies: The 48% of funding allocated by GF to private sector participation is a challenge, especially with the fact that many faith-based organizations do not include condom-promotion as part of their intervention, and furthermore lack the ability to handle bigger financial resources. More stringent registration mechanisms for NGOs were advised.

Procurement Policies, Systems and Capacities: Management weaknesses were identified (personnel, logistics, tools and manuals, monitoring and supervision and strengthening), concluding with the need to create effective Team Work.

Resources-related matters: High cost of ART medicines and supplies against limited funds available, access to additional funds (e.g. for logistics, infrastructure, diagnostics, etc.), foreign exchange losses / currency fluctuations were identified as additional challenges.

Quantification: Quantification / forecasting problems are encountered by all. Absence of data and statistics for planning and decision-making is a common problem. Forecasting the


number of patients for ART. Treatment regimens vary from country to country and adherence to regimens is a challenge.

Paediatric ART: The challenges include diagnosis and treatment, as well as care and support, especially with the progressive increases in the dosage of the pediatric formulations.

Supplier related matters. These include the continued supply of ARVs, the challenges of long-term forecasting, unfavourable payment terms, different pack sizes and labeling requirements, listing and de-listing of products and changes in treatment guidelines.

Challenges in regard to storage. These include: provision of adequate storage (capacity and optimal conditions) and safety. Also, the security problems associated with ARVs:

Pharmacovigilance of ARVs, and Rational Drug Use. Monitoring drug resistance and Adverse Drug Reactions.

Human resources and Technical Capacity. Lack / shortage of pharmacists and other human resources is a problem. There is inadequate capacity of laboratory support services mainly due to shortages of human resources. The issue of brain drain was discussed with the conclusion that it is good to develop motivation for staff. It is also imperative to develop Team Work of all involved in ART.

Integration and Coordination. Various coordinating mechanisms are applied in the different countries. There is a problem of coordination among the donors and sub-recipients, as disbursement of funds, reporting and accounting systems are negotiated with donors. The need for integration into existing targets, and synchronizing availability of supplies with program launch was highlighted.

Programme Evaluation/Reprogramming: The need as well as the urgency of conducting Monitoring and Evaluation and Operations Research was identified.

3. Identified Technical Assistance needed by countries include:

9 countries out of the 13 present requested for Technical Assistance of various types: These included requests on Intellectual Property Rights; (Patents); Forecasting; Procurement (including pricing); Supply Chain Management (Storage, LMIS, Inventory Control); Quality Assurance (including support to NDRA for Registration, QA, QC, Pre-qualification); Procurement of non-health products; and Rational Medicine Use (STGs, Monitoring Drug Resistance, Adherence to guidelines, ADRs). Most of the requests (20) did not specify the partner for the TA; however, a few (5) specified some UN agencies: WHO, UNAIDS, as well as MSH and JSI.

The financing source for most TA requests (18) was the GF grant, while some sources (6) were the UN agencies, PEPFAR, USAID and SWAP). By number of countries, 8 depended on the GF grant, while other funds identified for countries included PEPFAR (2), USAID (1).


4. Key Recommendations from the workshop are:

It is advisable for countries to select simple treatment regimens, which have proven effectiveness. It is also important to balance quality with affordability. AMDS can be of assistance to countries in product procurement and testing.

Generic reference generic guidelines on procurement should be prepared for countries. A template of 4-5 pages on draft agreements should also be prepared and circulated for the use of countries

To ensure effective quality assurance, countries should adhere to products in WHO pre-qualification list Each country should issue a request from the authority responsible for health to the WHO to assess QA systems in terms of needs and appropriate interventions.

Pooled procurement of ARVs may be the answer to supply challenges. If this is not possible at least there should be information sharing among countries in regard to supplies. In the long term, local manufacturing in the African countries with the manufacturing capacity should be considered. However, comprehensive recommendations are expected when the report of a WHO study, currently in progress, on the feasibility of local manufacturing is completed.

It is necessary for procurement authorities to evaluate national IPRS situation and determine whether changes are necessary to take advantage of TRIPS flexibilities

• The long-term training needs for the development of the capacity of countries was highlighted and it was suggested that in the future the Global Fund procurement planning should consider the full involvement of the national development partners in making the country’s proposal.

• Monitoring and evaluation of procurement/supply systems are necessary-to check manual system indicators (stock, stock outs, wastage rate, order fill rates, etc.) and to use electronic reports to update inventory, and provide feedback systems to facilities.

• A lot of resources have gone into capacity building; it is vital that feedback is given regularly

• It was raised that the GF should focus not only on the output indicators, but also the process indicators, such as the time lag between receipt of funds and when goods reach the CMS, and stock outs—frequency and duration. WB and GF should agree on indicators. However, it was also emphasized that the GF is mainly a fund raising and granting agency.

5. The key outcomes of the workshop are:

• The main outcome of the workshop is seen in the progress made by 5 countries in advancing from Phase 1 to Phase 2 (i.e. from PSM Plan in progress to completion of PSM Plan), leaving a total of 6 countries in Stage 2 at the end of the workshop.

• Participants from countries that were at advanced stages of the Global Fund approval and implementation, also benefited from the workshop as different countries in various stages of grant uptake and implementation learnt from each other. Different and novel experiences were presented and discussed, and useful templates shared among countries, during group discussions, presentations, and in the plenary.

• The new Global Fund Template was presented by Mr. Lalvani, as composted during the workshop from the several comments and deficiencies noted in the earlier versions


6. Next steps:

The need for countries to have a national institution to develop and enforce National Medicines Policies which should include aspects of selection, safety, efficacy, shelf life of products and rational use and guidelines for implementation. There should be the establishment and capacity building of technical committees with clear Terms of Reference and wide consultation with multi-sectoral groups

Quality Assurance is an emergency. Radical steps should be taken to redress the situation by promoting drug regulation and quality assurance systems in order to strengthen National Drug Regulatory Authorities

It is crucial to have a coordinated MIS for the entire country: It is important that indicators developed move with the Three Ones (one National framework, one institution, one M & E system), so we do not create a new indicators for each funding source.

It has been documented that M&E has been weak throughout the history of pharmaceutical management. There should therefore be comprehensive capacity building of managers at the primary levels of care for M& E. This may need joint technical assistance to define objectives, data needed, and the framework

WHO has developed a core indicator manual, starting from policy to use. Some of these indicators have been tested in some countries, including Nigeria. AMDS and countries should refine these tools to a small set of easily managed indicators. They should be available by the end of 2004 preferably.

• We need to track ADRs on drugs so any ARV that proves too toxic can be quickly taken out of the market. Operational research on HIV treatment cohorts still needs to be worked out. Adherence forms for ARV ADR will be cohort and sentinel mainly to identify the common toxicities so as to cause the surveillance to be better driven.

7. Conclusions:

A great need for Technical assistance for moving forward the PSM plans had been identified, hence the workshop. One of the greatest challenges that had emerged is that of procurement.

The true objective of the meeting was to enhance the saving of lives, and urgently too, thus requiring a facilitated and speedy approval of proposals in stages during the workshop. The need to take exceptional measures to actualize the goal of mitigation the effects of HIV/AIDS was re-echoed, as well as the necessity to keep to the objectives of the Three Ones.

The outcome of the workshop was very tangible, especially the approval of several country PSM plans

The choice of the participants was seen as very appropriate, and experiences shared, especially by those implementing made the workshop an incredible learning process for every one

Some Capacity building programmes on ARV and Related supplies (PSMP) for 2005 were announced, at regional levels, and a 2-phase national level. Then PSMPs are global


training events financed by The Bank, Dutch, Canadians, WHO (TA) UNAIDS (for 2005)

An estimated US$2.7 billion is to be committed to SSA by the World Bank, Global Fund and Bilaterals (excluding PEPFAR). The AVAILABLE FINANCING FROM ALL SOURCES IS TO BE COORDINATED

The need for a coordinated effort on the one national plan, harmonized procedures and reporting, regional knowledge sharing, resources sharing, as well as joint reviews and follow-ups was concluded.

Appreciation was expressed to all the agencies that contributed to the success of the workshop


Day One: December 2, 2004 Synopsis The days proceeding included the opening ceremony and five presentations on the overall objectives and expected outcomes, procedure and product selection, followed by a plenary discussion. Group work and subsequent discussion on the same subject followed this. Thereafter a short meeting of partner organizations took place. Highlights of the Presentations 1. Objectives of the PSM Workshop: Dr. Jos Perriens, WHO 2. Briefing on Workshop Proceedings: Dr. Vincent Habiyambere, WHO

Dr. Habiyambere presented on the procedures that would be followed daily during the workshop, as follows.

A morning session, which would start with an opening presentation, followed by questions and clarifications

A Break-up into 3 groups to discuss important issues related to the PSM plan, and in line with the implementation of the different components. This would also involve countries and agencies sharing experiences, outlining challenges and deliberating on possible solutions. A facilitator was to be assigned to each group, who would assist the group during the deliberations. The group were to elect a rapporteur to document and present the group discussions in the plenary, immediately after the group session

These were to be followed by afternoon sessions, designed to be a hands-on time to work on the PSM plan by the participating countries.

Participants were encouraged to take advantage of the presence of the various development partners and agencies for assistance with their proposals and other relevant issues.

Each day a facilitator for the session was designated Rapporteurs for the workshop were Dr.Catherine Atinuke Adegoke and Dr.Besrat

Hagos, with some inputs from Ms. Ethel Capuno and Ms. Laila Akhlaghi Each evening there was a facilitator meeting to assess the proceedings of the day

and plan for the following day

In addition, announcements were made on scheduling of appointments with different organizations/people and lessons learned. Each participating agency / institution declared its conflict of interests in the workshop.


3. The Procurement and Supply Management Plan: A Key Step Towards the

Implementation of Global Fund Grants: Dr. Ben Eiichi Seki, GFATM

The presentation Focused on the status of the Global Fund grants and the process of grant approval, with emphasis on the Procurement and Supply management Plan.

The Global Fund portfolio consists of approved proposals for a total of US$ 3.1 billion

over two years (Round 1-4), with US $ 1.7 billion towards HIV/AIDS programs. Overall this involves more than 300 grants (components) in 128 countries in the world, of which 138 grants are for HIV/AIDS in 101 countries. Out of this more than $ 685 million had been disbursed by end of November 04.

Highlighted the Global Fund process from grant to implementation and the PSM plan

development, with emphasis on the roles and responsibilities of the parties involved in the process.

Introduced key Global Fund documents, including the Guide to Global Fund’s Policies

on PSM, the three versions of the Guide to Writing the PSM Plan and the Price Reporting Mechanism.

Briefly explained the key components of the PSM plan using the latest version of the

guide to writing the PSM plan.

Briefly described the PSM Assessment tool for LFAs to conduct the PSM assessment – available in the GFATM website.

Questions and Clarifications The presenter and other partner organizations provided responses to the questions and comments raised as follows: Question: How could countries access funds for technical assistance before the Global

Funds are disbursed? Response: There are several options, including retroactive funding and approaching the

WHO and UNAIDS Country Offices to mobilize funds for short term Technical Assistance. However, there is no straightforward answer that applies to all countries. Portfolio managers may have to check for the most appropriate funding mechanism.

Question: How can participants form countries that are at advanced stages of the Global

Fund approval and implementation, such as Uganda benefit from the workshop? Response: Different countries in various stages of grant uptake and implementation need to

learn from each other and that was the essence of breaking into different groups.


A similar workshop in the past, comprising participants at various stages had highlighted mistakes and successes of those that were more advanced in implementation and constituted lessons learnt for all the participants.

Question: What is the position of the Global Fund in regard to the procurement of medicines

that were approved by the recipient country, but not pre-qualified by the WHO. Response: This subject needed further discussions, and will be tabled again at the next board

meeting in April 2005. In the meantime, countries could continue funding those drugs that were approved by the Regulatory agencies of the recipient country.

Additional comments On the need for TAs, it was suggested that twinning arrangement for technical assistance was a possibility and should be considered by GFATM and GFATM agreed to consider the issue. There was a concern that the workshop focused on PSM planning only for the benefit of GFATM and did not consider the national requirements. It was suggested that countries should be able to use this same format to avail other funds. The long-term training needs for the development of the capacity of countries was highlighted and it was suggested that in the future the Global Fund procurement planning should consider the full involvement of the national development partners in making the country’s proposal. 4. Overview of the Procurement Cycle: Product Selection: Ethel Capuno, UNDP

The presentation highlighted the importance of product selection as a vital link in the wide network of factors affecting the success or failure of the battle against HIV/AIDS and the delivery of health care in general.

Discussed the Rationale for Product Selection as a prerequisite information in the for the procurement plan.

Highlighted the basic principles of procurement, the types of products to be considered for procurement, the WHO and National guidelines for the selection of the items, general considerations for product selection and the key players in the process.

Mentioned the challenges of keeping up to date in the developments of ARVs, the need for collaboration and coordination of product selection among multidisciplinary groups and consideration for quick response during crises.

Proposed relevant professionals and organizations that could be consulted in the process of product selection.

Discussion Questions and Clarification The presenter and other partner organizations provided responses to the questions and comments raised as follows:


Question; how could keeping up-to-date with new developments in ARVs and the selection of appropriate products be reconciled with long-term agreements in respect to supply. Responses: Long-term agreements should not be limited to fixed quantities of products and

procurement lists can be changed if treatment guidelines change. Agreements may be for a certain number of years (usually 1-2 years, renewable annually and that it is possible to get volume discounts for one year estimates with secured financing.

Question: What happens if a country wishes to procure medicines that are in its own national Guidelines, but not in the WHO guidelines. Response: For the interim the Global Fund dictates that we stay with the WHO List and later a good justification would be required to divert from the WHO List. Question: What work is being done in the area of Pharmacovigilance of ARVs? Response: Negotiations are still going on with a few institutions and some training has been conducted. Some staff have also been recruited for the purpose, but they have not started work. 5. HIV Medicines Selection: Experience from Uganda: Joseph Serutoke, Essential Drugs and Medicines Policy, WHO/Uganda

The presentation highlighted the response Uganda adopted to HIV/AIDS control and care since 1986.

The Ugandan strategies involved strong political commitment, involvement of all stakeholders (PLWHAs) and partners, decentralization of implementation of HIV/AIDS activities, provision of care and support in a comprehensive Package that included VCT, Treatment of STIs & OIs, PMTCT, HBC, Palliative Care and recently ART.

This resulted in high levels of awareness about HIV, positive behavior change indicators and declining trend of HIV Infection among pregnant women attending ANC: 30% in 1992 to 6.2% in 2003.

Elaborated the process of the implementation of the various stages of ART in Uganda, which was introduced in 1992 through a clinical trial initiated by Joint Clinical Research Centre (JCRC) and expanded during the Drug Access Initiative in 1998 with the support of UNAIDS and 5 Pharmaceutical Companies.

Highlighted the establishment and roles of a National Advisory Board and a National Committee on Access to ART.

Highlighted the current status of ART in Uganda, giving figures of patients accessing ARVs at 31,000 as September 2004, of whom 25 % receive free medicines.

Listed the current challenges and planned next steps for ART in the country. Discussion The presenter and other partner organizations provided responses to the questions and comments raised as follows:


Questions and Clarifications Question: Has Uganda considered revising the first line drugs? Response: The need for revising the first line treatment had been noted and it would be dealt

with in the next stage. Question: What criteria were used to select the 25% receiving free ARVs? Response: The 25 % getting free ARVs were those who had been part of the support groups and

had been receiving free ARVs previously. Question: How were they able to get continued supply of ARVs, particularly paediatric

dosages? Response: They have not solved the problem entirely and that they had been improvising. As far as

the general continuity of supply was concerned, there was a high degree of commitment to scale up. However, that would depend to a large extent on the smooth flow of funds from donor to government.

Question: How the issues of equity and access were being addressed and has Uganda tried the cost sharing option, as it buys ARVs at high prices and then gives them out for free?

Response; The government has committed itself to free ARVs for the people. Question: What happens if some people feel that they can pay for their own drugs, even

though their CD4 count is higher than 200 Response: Such issues are still being grappled with in the programme. Question: What to do if the enrolment surpassed the number that the funds available can supply drugs for? Response: This has to be carefully considered before the initiation of therapy. Question: What was being done on paediatric ARVs? Response: A great deal of work was being done to improve the ability to diagnose and treat

the infants, especially as they need progressive increases in the dosage of the pediatric formulations. Serious discussions were also going on with manufacturers.

Additional Comments The presentation generated a number of general questions on sustainability of supply. The response from partner organizations was that so far only 30-40% of the funds allocated had been disbursed and that it is necessary to use up the available means to tackle the problem without delay, while we look into the question of sustainability.


Group Work Presentations Group Presentation 1: Feedback on Key Issues on Product Selection

Some countries do not have national guidelines, but most countries have national essential medicines lists. However, most of some of them are not up-to-date

Treatment regimens can vary from country to country and adherence to regimens is a challenge

High cost of medicines against limited funds available Institutional arrangements to consider the formulation, strength, safety, efficacy and shelf

life aspects of products Weak Infrastructure for Medicines Supply Management How to prioritize among a number of diseases Capacity of the end-users to use the products Non-availability of statistics/information to help establish rational use of medicine Aggressive promotion by manufacturers

Group Presentation 2: Feedback on Implementation of Key Components

WHO guidelines and list could be used, while the national ones are under development or being updated. Enforcement to be ensured.

It is advisable to select simple treatment regimens, but of proven effectiveness and easy for patients to comply with

To balance quality with affordability ensure effective quality assurance, consider products in pre-qualification list

The need for a national institution to develop and enforce National Medicines Policies o Establishment of technical committees with clear Terms of Reference could be

considered o Wide consultation with multi-sectoral groups o Wide consultation with multi-sectoral groups

National Medicines Policies should include aspects of selection, safety, efficacy, shelf life of products and rational use and guidelines for implementation

o The need for common understanding on the country’s policy with regard to selection

Incorporate training on rational use of medicines in procurement plans o Train health workers, students o Develop and disseminate the treatment guidelines o In-service on the treatment guidelines

Decisions on prioritization of products should benefit the majority of the beneficiaries o Consider demography and burden of coexisting diseases o Consider vulnerable group (based on age, gender, etc.)

Develop at least the minimum infrastructure for medicines supply management Tap the resources of civil societies, UN, CBOs who have been there and have baseline

information Ensure transparency in the selection processes


Group Presentation 3: Feedback on Technical Assistance necessary to implement PSM Plans

• There is need for TA in the following areas

o to source the medicines, particularly the paediatric preparations o to strengthen the committees and sub-committees, clinicians / pharmacists

interaction. o Technical and laboratory equipment selection is more challenging o To update the country’s protocols o Forecasting and quantification o Development of specifications for medicines and medical equipment o Selection and quality assurance

Discussion on Group Presentations

Which products to consider for registration and at what level to provide treatment with ARVs? We have to consider the level of care for ARVs. So far this has been limited to tertiary care in most countries, but as we scale up treatments we should be moving down to the lower level health facilities.

The need for the development of a Master Plan and to establish a multi-sectoral body (including the private sector and NGOs) that will be responsible for the implementation and monitoring of the Master Plan

Currently various faith-based organizations and NGOs are providing treatment, including Home based care. Drug resistance can develop, if medicines cannot be collected on time due to transport problems. It is therefore necessary to make provisions for transport of the community workers to collect medicines for this purpose.

Assessment of the capacity and assistance needs of each implementing agency So far discussions have focused on selection and increasing access to ARVs drugs. But

the issue of the capacity to monitor adverse drug reactions has not been effectively addressed. There is need to follow up on that.

There is need to update the protocols regarding product selection. There is need for common understanding of drugs policy. There is also a need to use the ART guidelines to establish the patients Technical assistance is needed to:

o Forecast for the government o Technical specifications of the medical equipments and drugs o Expert—capacity building for staff to come up with the specifications of quality

assurance o Facilitation of the processes—where there are funds

Treatment literacy is important –for patients to be told that they need to have CD4 count of less than 200 to be started on ARVs.

TA is needed to source special formulations, particularly pediatric medicines Clinicians, pharmacists, everyone need to be involved in procurement—this involves a

lot of interaction between different people. Sometimes, the real problem is with laboratory reagents, and not drugs. Pricing issues should be sequel to selection—selection is the first issue.


At the end of the day the partner organizations met to discuss their observations and assessment of the day, as well as plan and strategize for the following day’s session.


Day Two: December 3, 2004 Synopsis The days proceeding included three presentations, one on Patent laws and two on the PSM plan. This was followed by group discussions of participants followed by group presentations and a plenary discussion. The participants then continued working on their respective PSM plans, supported by partner organizations. Finally there was a brief demonstration of software on Management Information Systems (Quantimed), followed by a short meeting of partner organizations to evaluate the progress made during the day. Highlights of the Presentations 6. Technical Overview of the PSM Plan: Paul Lalvani, GFATM

This presentation was a detailed version of a previous presentation by Dr. Seki., with a detailed description of Global Fund Process.

Mentioned the three scenarios, where the PR could be responsible for all procurement, where PR completely out-sources the procurement and where the PR only coordinates the procurement.

Led participants through the PSM template and described on how to develop the Procurement and Supply Management Plan with emphasis on ARVs.

Indicated that the plans are for 1-2 years. The plan may change in the second year, in which case the Global fund should be informed on the change. However, if the changes are marginal an email would suffice. Major modifications would require some mechanisms specially if impacting changes in the grants.

Advised countries to keep the PSM simple and short, about 10 pages. One can put annexes to explain issues. The plan should be based on existing systems and data and the option of outsourcing to specialized agencies should be considered when capacity is lacking. Follow up with price reporting mechanism and tracking of funds would be required.

The presenter informed participants that he would help countries to prepare and finalize the PSM plans, including approval of some sections or the whole document.

In conclusion, he highlighted that the true objective of the meeting was to save lives. To this end, proposals would be approved in stages during the workshop, as it would not be right to take 6-18 months to write projects when so many people were dying.


Questions and Clarification The presenter and other partner organizations provided responses to the questions and comments raised as follows: Question: What is the GF standard on reviewing and approving the PSM Plan? Response: Some countries submit to LFA. Completed PSM plan should go to the Portfolio

Manager and the Procurement Group. Turnaround time should be within a week, max. 2 weeks. LFA makes an assessment and goes down to the countries. It takes a few months, but GFATM is working on shortening it.

Question: Who makes the final approval? GFATM or LFA? Response: There are possibilities when LFA did not catch some lapses in the proposal, so

when such issues are noted by GFATM the documents are sent back to the countries.

Question: Should quantifications for products to be funded by other sources be included in Annex 1 of the PSM template?

Response: Only quantities for procurement with Global Funds need be included in annex 1. Annex 2 provides for other funds received, but it is not necessary to include quantities of products.

Question: What are the mechanisms for accounting, where several sources of fund are available? How flexible would LFAs be, if the invoicing and accounting did not match with the funds?

Response: There is no single answer to this question. Countries must to have financial system where partial charging to various sources is possible.

Question: Many countries are looking at GFATM as the key to closing the gap. Response: Question passed on to countries. No country answered. Question: How much harmonization is there for auditing? Response: The finance departments of GF and WB will be able to answer those questions.

But, the program managers are faced with the issues, not the finance people? 7. Forecasting – Estimating Needs: Helen Möller, UNICEF

The presenter presented a review of the elements of comprehensive clinical care packages

for the home based care, community based care, and facility based care. Knowing how one’s HIV status as the key to the treatment. The strategy should include

regular STI screening; prompt treatment and condom distribution should be part of the care of PLWHA.

The presenter listed the key issues to be considered for the estimation of requirements as follows: o Postulating a patient profile at site of service delivery, including the numbers of

adults, pregnant women, children and the potential to develop ADR on treatment failure

o Estimating the growth in numbers of patients on treatment, based on the current numbers that need treatment


o Estimating the numbers of packs needed to start with per recommended treatment and multiplying the cumulative number of patients with the number of treatment packs regimen.

o Preventing stock outs by calculating safety stock level, estimating the lead time for arrival of stocks and deciding on an ordering interval and re-order triggers.

Challenges to be expected, include the need for coordination, integration into existing targets, synchronizing availability of supplies with program launch and conducting monitoring and evaluation and Operations research

Finally the presenter cautioned participants that procurement defines the success or failure of an ARV treatment program and reiterated the need for a drug supply strategy at facility level, including a recognized order interval and lead-time and to have an idea of stock in the system, info on expiry dates, etc.

8. Intellectual Property in Medicine Procurement: Patrick Osewe, World Bank

Definitions: o Intellectual Property Rights (IPR): the rights given to persons over creations of

their mind. It gives the creator an exclusive right over the use of the creation for a certain period of time. The product should be unique and un-obvious with some value in the market.

o Trademark: a right granted to exclude others from the use of a sign that creates confusion in distinguishing the goods or services of one enterprise from those of other enterprises (e.g., Coca-Cola)

o Copyright: right granted to author of “expressive” work (e.g., book or song) to prevent others from copying and distributing.

o Patent: a right granted to the inventor of a new product to exclude others from its making, using, selling, offering for sale or importing for up to 20 years from date of application.

o Rights in Data: Protection against “unfair commercial use” of data submitted for marketing approval of new chemical entities

On January 1, 1995 the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS Agreement”) entered into force

The TRIPS Agreement provides various “transitional arrangements” in favor of “developing” and “least developed” members

TRIPS Agreement rules do not directly apply in most national legal systems, but instead are implemented by legislation

The Doha Declaration: o Each country can determine if a national emergency or circumstance of extreme

urgency exists o Least developed members can disapply patents and data protection rules until

January 1, 2016 For procurement specialists to understand what is permitted, and/or seek expert guidance

from relevant experts Features of the International IPRs System Generic Alternatives Least Developed Countries (LCDs) do not have to enforce patents


Quality must be maintained and assured LDC are given special / maximum flexibility by WTO and may elect not to enforce patents and/or

date protection, so that govt. has a free hand Developing countries may seek voluntary license from patent holder (or price break) Differential Pricing – a patent holder may decide to sell at a lower price because of specific

country situation such as emergency.

Questions and Clarification In the discussion session that followed the presentation, the following question was asked responses provided by the presenter / partner organizations. Question: Shouldn’t WHO and WB help the countries to locally manufacture generic medicines? Response: It does not necessarily become cheaper for countries to produce generic drugs,

given the heavy investments required. It may also be difficult for the generic manufacturers to meet the standards for WHO pre-qualification.

Highlights of Group Presentations Group Presentation 1: Feedback on Issues to cover in PSM Plans The status of PSM plans of countries and major issues in regard to its development were briefly discussed. Group Presentation 2: Feedback on Issues Around Implementation Procurement Policies, Systems and Capacities

The different countries have different capacities and experiences in regard to implementation of procurement policies

In Tanzania there is a Procurement Act, with guidelines for tender procedures. The Medical Stores, a department of the Ministry of Health is responsible for procurement of pharmaceutical

The Principal Recipients vary from country to country. In most cases the Ministry of Finance is the PR

There are also problems of accessing donor funds in time.

Coordination Various coordinating mechanisms are applied in the different countries. In Tanzania the

Ministry of Finance is the PR, but the AIDS Commission is charged with the responsibility of coordination and the National AIDS Control Program manages issues of treatment and care.

In Tanzania SWAPs is in operation, but sometimes there are problems of delays in donor funds, disrupting treatment programs.


Namibia does not operate SWAPs. There is a problem of coordination among the donors and sub-recipients as disbursement of funds, reporting and accounting systems are negotiated with donors.

In Angola suppliers are requested to do different invoices / accounting according to donors and products are delivered directly to the donor’s or the beneficiary’s warehouses, but only one enters into contract with the supplier, to benefit from volume discounts possibilities.

Quantification

Quantification / forecasting problems are encountered by all. In Namibia only one donor (CDC) and the NACP gather patient treatment information centrally. Quantification is impacted by eligibility requirement changes.

Absence of data and statistics for planning and decision-making is a common problem. Human resources and technical Capacity

Lack / shortage of pharmacists and other human resources is a problem Inadequate capacity of laboratory support services mainly due to shortages of human

resources. Presentation 3: Feedback on Technical assistance Needs for Implementation

Technical assistance is needed on: To develop Logistics Management Information and Inventory Control Systems To help develop financial management systems Intellectual Property Rights issues Forecasting and quantification


When procurement capacity is inadequate, it is better to subcontract Selection of contractors should be done on competitive basis, even among UN Agencies.

Three contractors can be contacted to give quotes as to the cost of the medicines, the procurement fees and time frame for delivery, based on which one can be selected.

Pre-qualified Procurement Agencies are also available, but it is also necessary to select among them competitively

How to switch from one agency to another Below a certain threshold it is possible to negotiate directly with a UN Agency WHO charges lower percentage of procurement fees, but UNICEF supplies faster UNDP has a pharmaceutical Management that can trace the use of medicines to all end

users


Plenary: Introduction to the development of the PSM plan: P. Lalvani In this session Mr. Lalvani gave further clarifications on PSM plan development and updated participants on the progress in the development of PSM Plan of countries. This was followed by country specific work on PSM and implementation plans Demonstration A short demonstration of an MSH quantification software (Quantimed) by Ms. Laila Akhlaghi. At the end of the day the partner organizations met to discuss their observations and assessment of the day, as well as plan and strategize for the following day’s session.


Day Three: December 4, 2004 Synopsis The days proceeding included a three-part presentation on the subject of Storage, Logistics Management Information System and Inventory control, followed by discussions. A Breakout Group Session aimed at identifying the key issues in the PSM sections already discussed the first 2 days of the workshop followed. The 2 groups were to discuss and present on the subject of implementation concerns and the technical assistance needs for the implementation. The afternoon session started with a follow up presentation on the development of a PSM plan, followed by discussions on the same subject. Countries then continued working on their respective PSM and implementation plans. The day; work ended with a partner organizations’ meeting. Highlights of the Presentations 9. Storage, LMIS, Inventory Management and distribution: Augustine Bahati, Jayne. Waweru, Steve Kinzett (John Snow Inc.?) Logistic cycle: Comparative illustration of AMDS PSM Cycle and Deliver’s Logistics Cycle was presented. The differences highlighted included ”Serving Customers” as part of the Deliver’s Cycle, giving high importance to the customer and there is monitoring and evaluation after every step. It also noted the importance of the LMIS component in the two Cycles

LMIS was defined as a system that collects data and summarizes them for decision-making.

As crosscutting issues whether the system is integrated or vertical, and whether the items are fully supplied or limited supplied commodities were mentioned.

Fully supplied commodities are those that are able to meet the client’s needs, while limited supply commodities are those that have to be purchased on the budget that is available e.g. ARVs for a limited number of people.

Oversupply is wrong procurement due to the dearth of or neglect of information to guide quantities in purchasing.

Storage: the purpose of storage is to protect the quality of the product and its packaging

throughout the supply chain and to make products available for distribution. Challenges to storage include: provision of adequate storage (capacity and optimal

conditions) and safety. Storage conditions of different items will be different. Some items need special storage conditions in different countries. e.g. Determine Test Kits.

The security problems associated with ARVs: What percentages should account for loss of ARVs due to pilferage or break-ins.

The need to consider the shelf life as part of the specifications for procurement At the time of receipt the commodity should have at least ¾ of its shelf life


The need for storage guidelines.

LMIS: The collection, collation and organizing of data to enable effective and timely decisions; the key to any logistics system. The main decisions to make in developing LMIS are what data to collect and what format the LMIS should have.

The three essential data items for LMIS are stock at hand, rates of consumption and losses and adjustments. Other data may include the types of regimens, what has been dispensed to the patient and expiry dates. As you go higher the type of data to be collected will be different.

Facilities should report at least quarterly. The system must be made as flexible as possible to accommodate a scale up Adjustments should be recorded accurately. Health educators should be encouraged to

report items used for training. Forecasting the number of patients we are likely to enroll for ART in the near future is

challenging, even when we have historical data. Monitoring drug resistance and whether the medicine is working, patient moving from

one regimen to another, number of defaulters, deaths (patient tracking) and Adverse drug reactions.

We cannot afford to stock-out The pharmacist at the CMS should be involved in the whole decision making system

rather than just data collection alone. Reporting formats: A display of samples of Ministry of Health – Kenya data collection

forms were made and described with examples. The advantages and disadvantages of aggregating data at the district level

Inventory Control: To maintain appropriate stock levels of all products, avoiding

shortages and oversupply. Who, when how to make orders: Min-max systems, re-order levels, just in time etc. What to integrate and what not to integrate. Priority products could be identified for a vertical system Monitoring tender progress and product monitoring (e.g. Recording products that may be

de-listed) The linkage between HMIS, inventory control and LMIS

Questions and Clarifications The presentation was interactive, with some of the answers being provided by the participants and their inputs are included in the highlights of the presentation above. The following is a summary of the questions raised after the presentation and responses provided by the presenters or other participants. Question: Should we go “high-tech” when developing LMIS? Response: Initial costs may be very high. However, it might be worth it. Question: How many levels of LMIS should we have for the ARVs?


Response: It will depend on the levels of HIV/AIDS treatment we have. The most efficient LMIS systems are centralized systems. What ever the system may be it has to fit into the existing system

Question: Who should be involved / trained in the LMIS system. Response: All those we intend to involve in the diagnosis and treatment need to be trained,

e.g. the lab-techs who will be using the test kits. Question: How often must inventory be done? Response: Quarterly inventory should be sufficient, as conducting a monthly inventory

would be too expensive. Question: How could we prioritize who should be starting on ARVs? Response: The service capacity may determine the numbers the numbers that can be

handled. We must also consider availability of the products for that number of patients. In every case patient data has to be collected to enable us plan for the changing numbers receiving ARVs

Question: Do you have suggestions on the magnitudes of orders that can be effectively

managed? Response: This depends on many issues, including the capacity and security of the storage

facility, the distribution system. However, it must be planned such that there are sufficient stocks at the facility level as a monthly reordering may not be appropriate, due to problems of transport facilities. It might be necessary to construct cages or burglary- proof bars for the ARVs for additional security.

It helps to map out the facilities and explore the use of existing private transport systems to ease the problem of transportation. Distribution may also be necessary outside the health facility, in situations where community based care is planned. In this case thorough consultation with the local people is necessary.

Question: What about outsourcing of the distribution? Response: This might not be the answer, as governmental institutions do not pay always their

bills on time. The successful cases of outsourcing are those that are financed by donors or other specialized agencies.

Question: Angola noticed late that there was a gap in the logistics costs and mechanisms in

relation to the fund for Malaria medicines. How could they fill this gap? Response: You may borrow from the next half of the project to cover the costs. Portfolio

managers can accommodate such modifications. As the cost of medicines usually tends to come down, you may be able to make savings there to balance the fund borrowed.

Question: How should regional warehouses be managed? Which functions should be

decentralized and which ones should remain at the central level? Response: Manage the regional warehouses at the same level as the central one.


Question: How do we determine buffer stocks? Response: This requires expertise that develops with time. Additional Comments and Recommendations:

Uganda has and Integrated Management Information System, but it doesn’t collect data needed for ARVs management. There is also a problem in recording losses.

The problem of recording losses is common to many countries; losses cannot be reflected in an inventory for political reasons.

Inventory Control Systems need time to develop. The central system may be suitable for medicines for opportunistic infections, but perhaps not for ARVs.

The tender document for the ARVs should have mandatory specifications for shelf life. ARVs should not be repacked out of their original dispensing, as we cannot guarantee the

stability out of their blister packs. An adequate and functioning Cold Chain system is essential—the needs may differ from

country to country and in between countries. Highlights of Group Presentations Group Presentation 1: Issues to cover in PSM plan Progress of PSM plans of countries and major challenges were discussed. Group Presentation 2: Feedback on Issues Around Implementation

Paediatric care and Support o The issue of paediatric formulations needs to be addressed. o There is need for guidelines for the treatment of children. o How have countries catered to this in their proposal or implementation? What is

their perspective? o What can be included in the PSM plan to cater for paediatric care and support?

Coordination

o How to mix funding streams in situations of multi-donor funding o How countries could program for multiple diseases o How to organize the accounting for products from different sources o The use of different products and treatment regimens using different sources of

funding: Some countries are using their own funds to procure fixed dose

combinations and other resources for other treatment regimens In Namibia government funds are used only for fixed dose combinations In Tanzania the Government distributes generics and branded products

through its own funds. The numbers of patients to be supported by the respective funding are indicated.

o How to account and report to different donors and partners o Which level of health workers should provide ARVs?


Supplier related matters

o Getting continued supply of ARVs is a problem o There is a long lead time for the supply of ARVs o The challenges of long-term forecasting o Unfavourable payment terms o Different pack sizes and labeling requirements o Listing and de-listing of products o Changes in treatment guidelines


Paediatric care and Support

o Children can be treated with currently available products. The initial intervention

should be administration of Cotrimoxazole Prophylaxis until HIV is ruled out o Guidelines have already been released by WHO o There are dispensing problems in regards to paediatric dosages, as most facilities

don’t have glass-dispensing bottles and calculation of consumption becomes too complex.

o In Ghana the main problem is sustainability of supplies o Forecasting for paediatric requirements is a problem in the absence of figures. o In Tanzania the Government has made a small allocation for pediatric cases. The

program started with 200 patients with available products. There is a need for WHO to follow up the issue.

o In Nigeria local manufacture of generic paediatric ARVs has commenced o There is a need for research in this area; perhaps countries could use GF funds for

this purpose. o The possible use of GF funds for operational research needs follow up. o The World Bank supports operational research activities and interested

participants could refer to a WB handbook on paediatric AIDS in Africa for further details on the subject. There is also Columbia University document on tracking of paediatric cases.

o Tanzania would have wished to include paediatric medicines in the PSM plan, but due to the problems associated with forecasting they decided to look for other sources of fund for now.

o For now operational research could be included in the PSM plan, as there is no GF policy that says it will not finance such activities.

Coordination

o The use of different treatment regimens by different programs / project is

confusing to health workers and patients. o In one country, the government is supplying generic drugs to the same hospital

where a donor is supplying branded products.


o There are partners with preference to certain areas where the government also supplies. In a hospital with the highest number of HIV patients, there are already 4 organizations supplying different brands of ARVs, using their own treatment guidelines. It is not easy to ask them to stick to guidelines or to stop.

o This is indeed a worst-case scenario, health workers must be confused and the possibility of accidents is very high. It is necessary to address such situations at a higher level and a political decision has to be made.

o As far as generic versus branded products is concerned, if the generic products are in the WHO, they have passed bio-equivalence tests and they can be used interchangeably. The problem is that the donors may not allow that to happen.

o In Tanzania all stakeholders involved in the treatment issues meet on a regular basis, under the guidance of the lead agency, the Ministry of Health. Without that forum, coordination would be difficult.

o In Tanzania accounting and reporting to different partners is a challenge. Each of them requires an invoice, but this is not easy to comply with. The suppliers would have to be asked to prepare separate invoices depending on the source of the funds for the supply? As a Govt., they want to capture every fund that comes from various funding sources, without having to deal with a complicated reporting system and they hope that GFATM would agree on a common system.

o Kenya, Uganda and Namibia have used a common reporting mechanism to address the problem of reporting to partners. This mechanism should be documented and shared among countries. For multiple programs in one facility, documentation should be discuss and see how WHO and UNAIDS can do to bring the donors together.

o In Malawi, AIDS program is a basket approach where WB and other donors have agreed on one accounting and monitoring and reporting system. The Ghana Health Sector Investment Programme is also using basket-funding approach and the partners have agreed on a common reporting system. Donors do not insist on separate invoices.

o In Mozambique GFATM is a part of the Sector-Wide approaches to funding. The SWAPs may be ideal for harmonizing financial reporting, monitoring and evaluation systems.

o Uganda encountered a situation where demand overtakes protocol. In one case some donors did not follow protocol, but it could not take action, as there was also a shortage of ARVs. But currently this is being streamlined.

o There is need to have national plans and treatment protocols. Countries should not be responding to donor demands. The donors should be responding to countries needs and follow guidelines.

o The issue of guidelines and treatment protocols is crucial, particularly if we wish to allow lower level of health workers to treat with ARVs.

Supplier related matters

o Most Multinational companies require a lead-time of about six months. Most of

them do not keep enough stocks. They do not keep enough stocks, because they have no understanding of the situation of the third world countries.


o Concluding deals also takes a long time. This is further delayed by the fact that the companies do not often agree respond to the client’s banking needs. There was a case with Glaxo Smith Kline (GSK) not accepting requirements by a national central bank to give CIF offers, insisting that they only give FOB quotes. It took a long time to get them to accept this.

o Multinationals have long term plans for the production of several products and they may not be able to respond to the needs of the clients, currently GSK is changing the IT system, resulting in not being able to execute orders.

o Multinational have agreed to differential pricing for ARVs, but they are not committed to supplying. It seems that production capacity is not the only reason for not meeting the demands. They may have priorities within a manufacturing plan depending on the margins of profit.

o Increasing buffer stocks is not necessarily a solution, as increasing buffer stocks can result in increased wastages, as most ARVs have shelve lives of about 18 months. It will be necessary to order a large quantity, with a timetable for delivery, i.e. delivery of a certain quantity per unit time. But most Multinationals would not accept to such arrangements.

o Pooled procurement may be the answer. If this is not possible at least there should be information sharing among countries in regard to supplies. WB could consider pooled procurement by one or two countries in the same region, if volumes are significant. Common strategies should be explored to achieve this. Studies have been done on the feasibility of pooled procurements.

o In the long term, local manufacturing in the African countries with the manufacturing capacity should be considered. In Ethiopia a number of companies have expressed the interest to produce their products locally. Participants could refer to a discussion paper on the pros and cons on local manufacturing of ARVs. However, a full report is expected when the WHO study, currently in progress, on the feasibility of local manufacturing is completed.

o Long term forecasting is a challenge. Forecasting has been erratic. o The Global Fund also should give information on when the funds will be released.

When the funds are available, it may end up being disbursed on first-come-first-served basis.

o Payment terms are often not favourable. UNICEF requires 100% pre-payments. The same with UNDP, but they have made exceptions. But, IDA is more flexible. In respect to orders of up to US $ 20,000, they have even supplied based on a telephone order.

o CIPLA is much more flexible. It supplied an order worth US$1.6 Million without any prepayment.

o What could be done in case arise crisis in the supply of ARVs, as there was the case of the antimalarials ACT?

o IDA has a warehouse for buffer stocks. UNICEF also could have the product in its warehouses, but the products are meant for different destinations. Therefore the literature inserts and labeling could be different. There is also the problem of differential pricing. All this could result in complications.

o Listing and de-listing are also important factors in the continuity of supplies.


o Frequent changes in guidelines should be avoided, as forecasts will no longer be valid. It is important that we have the data to justify any changes in treatment guidelines.

o Long-term contracts with manufacturers may be the solution, provided that the one negotiating has the purchasing power

o Good forecasts, confidence of payment, sharing information are the key to guaranteeing timely deliveries.

o For the purposes of monitoring and evaluation it is necessary to document funds budgeted, funds requested, funds received, value of goods received and value of goods dispensed. This should be reported in the semi-annual reports.

o Global organizations should be able to negotiate with multinational manufacturers to lower the prices of ARVs. The Clinton Foundation (PEPFAR), the Global Fund and UN Agencies are already doing this. However, there is also the concern that if we reduce the prices of branded products, the generic manufacturer may have a problem of insecurity.

Additional issues were raised but their discussion was deferred, as they would be dealt with in the following days. These included:

o How to monitor Adverse Drug Reactions (ADR) and drug resistance o Allocating/Matching patients with different sources of products o Treatment related matters

Levels of care/where to treat HR Crisis in health sector, roles of professionals (nurses, health workers,

etc.) o Public/private sector collaboration on ART (e.g., mining corporations) o MIS – who will collect the data, how to analyze, feedback flow o Three 1’s o After procurement plan has been approved - how do we start? o QA/QC issues o Resources-related matters

Access to additional funds (e.g., logistics, infrastructure, diagnostics, etc.) Resources for PSM implementation Foreign exchange losses / Currency fluctuations

Group Presentation 3: Technical Assistance Needs for Implementation Plenary: Introduction to the development of the PSM plan: P. Lalvani In this session Mr. Lalvani gave further clarifications on PSM plan development and updated participants on the progress in the development of PSM Plan of countries. This was followed by country specific work on PSM and implementation plans At the end of the day the partner organizations met to discuss their observations and assessment of the day, as well as plan and strategize for the following day’s session.


Day Four: December 6, 2004 Synopsis: The day’s proceeding included two presentations on the subjects of Quality Assurance and the Procurement of non-health products. This followed by group discussions of participants followed by presentations and discussions in a plenary session. Thereafter two presentations were made: one on the patent situation of some HIV drugs, and the other on the practical implications of the TRIPS agreement. After plenary discussions on the same subjects, the participants continued work on their country PSM plans. Highlights of the Presentations 10. Quality Assurance: Thomas Lapnet-Moustapha (WHO/AFRO)

Quality Assurance ascertains that medicines reaching the patient are safe and effective. Two components of Quality and safety are: norms and standards, and drug regulation/quality assurance systems

Regulatory bodies are fully operational in only 1/3 of developing countries, while up to 1/5th of medicines are of poor quality, where they continue to harm and kill

National and international controls need strengthening, especially with globalization. Only 30 out of 46 countries (as at 2003) had comprehensive medicine policies. There is need to have the policies in a written form

Definition of Quality Assurance as “the totality of arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use. It also incorporates GMP and other factors such as product design and development (GLC, GCP).

Definition of Quality Control as the testing of pharmaceutical product samples against specific standards of quality. The dissuasive effect was especially noted

The objectives of the UN pre-qualification of medicines (equal opportunities, reduction of the risks of sourcing sub-standard, counterfeit, contaminated medicines, rapid access to quality medicines, and acceleration of contract awards) were highlighted

The PQ process was explained as an expression of interest, leading to inspection of manufacturing sites and products (a team work by international experts)

The achievements of the PQ project so far include the evaluation of some products, development of model QAs, enhancement of country capacities to produce ARVs and other priority medicines, development of country regulatory capacities to assess ARVs, more efficient procurement and quality control strategies, and greater international co-operation on medicines quality

The impacts of Quality Assurance on the PSM cycle were discussed, viz. Selection, Quantification, Procurement, Management, Distribution, and Utilization


Information was given as to the 2 WHO Collaborating Centres (CEQUAM/RSA and QCTUNIS/TUNISIA); and the 4 Regional Quality Control Laboratories, in Accra/Ghana; Harare/Zimbabwe; Niamey/Niger, and Yaounde/Cameroon.

Questions and Clarifications: In the discussion session that followed the presentation, the following questions were asked and responses provided. Question: Is interchanging allowed when there is a shortage of generic Fixed Dose

Combinations? Response: UNICEF is pursuing the same questions, because of the life changing potentials

of drugs for HIV/AIDS. One of the methods to prove interchangeability is through bio equivalence studies. The challenges imposed are still under discussions with WHO and drug regulators, such as FDA. The guideline is to completely test for the bio equivalence of each of the products after administration and compare with the FDCs. UNICEF has requested for the comparative dissolution rates of the de-listed ARVs.

Questions: The situation with bio equivalence studies for ARVs needs to be clarified.

How are they accepted? Are bio equivalence results from suppliers acceptable to the NRDA?

Response: The practices of bio-equivalence studies have been on for other medicines, and we should not waive aside the current practices in the countries; they need to be identified and adapted to ARVs. Bio-equivalence studies from suppliers may be accepted if they are well documented.

Question: How does a country handle the issue of defective goods, especially when a

procurement agent is involved? Response: It is the supplier’s responsibility to take back the goods, and it may be best not to

take the goods at all. There must be an instrument (a complaint clause) in place in the contract to address this possibility, even if it is generic, so that countries are not at loss with this kind of incidence.

It was emphasized that that countries remember that it is their national responsibility to maintain good quality in drug imports. For local production, pre-qualification of raw materials suppliers should be done.

11. Procurement of non-heath items: Ethel Capuno (UNDP, Manila) Non-health items were described as goods, services, and works. Technical definitions

also given. Contents of presentation covered the wide spectrum of procurement flow, including the

definition of terms, principles and methods of procurement, defining specifications/Terms Of Reference/Schedule Of Work, pre-qualification/selection of suppliers, evaluation of offers and negotiations, and contracts management


Specifications form the heart of procurement, and are of various forms TORs and SOWS should be clear and precise: SOWS are refined TORs drawn up for

works contract Different procurement methods were exemplified to include: request for quotation,

invitation to bid, request for proposal, and direct contracting Pre-qualification, eligibility to register, criteria for the selection of suppliers and of

evaluation of offer, quality standards, as well as negotiation and eventual contract award and administration were discussed. Need to clarify the Procurement Authority was emphasized.

Handouts on how to prepare TORs, to evaluate Consultants/Other Services, and sample page of UNWEBBUY were distributed

Questions and Clarifications: In the discussion session that followed the presentation, the following questions were asked and responses provided. Question: What happens when there is insufficient budgetary allocation, and there is only

one supplier? Response: We need to justify the situation of a lone supplier because of the risk of price

monopoly. The best practice is the aggregation of demand, followed by negotiation for price reduction

Question: There are incidences of actual and potential conflicts of interest. What to do? Response: The best practice is to hire a consultant to prepare specifications or design of

programmes. The designers of the specifications or TOR must be precluded from participating in the actual supply of goods or implementation of works. Hence there must be adequate compensation for the design.

Question: Most suppliers require pre-payment for goods. What can be done to change this

clause? Response: UNICEF is advising warehouses not to provide credit because of the risk that a

single badly managed ARV contract can bankrupt the entire system. IDA also does not usually offer credits. To facilitate uninterrupted supplies, Global Fund is working on guaranteeing procurement arrangements that have received approval for funding.

12. Patent Situation of HIV/AIDS-related drugs in 80 countries: Jos Perriens (WHO/HQ)

Many countries represented at the workshop were noted to be member states of the African Regional Industrial Patent Organization (ARIPO)

Tables were presented on the patent situation of first line ARVs; individual countries involved were shown (South Africa is highly affected). The effective dates ranged from 2006 to 2013


Patents on some second line ARVs were also listed. Questions and Clarifications: In the discussion session that followed the presentation, the following questions were asked and responses provided. Question: It is a surprise that so many countries are ARIPO states. Are the countries even

aware of this fact? Response: It has taken a very long time for most countries to understand the interpretations

of DOHA Declaration Question: Lesotho fell into the trap of approval of patents. Is there a way of getting out of

ARIPO? Response: This was as a result of Lesotho’s default in answering quickly to the patent query.

It may appeal to the ARIPO counsel meeting

13. Intellectual Property Rights in Medicines Procurement: Patrick Osewe (World Bank)

The least developed countries (LDCs) enjoy the maximum flexibility on TRIPS agreements. They may elect not to enforce patents and/or data protection until January 1, 2016. In terms of international obligations, the government has a free hand, and should take appropriate steps to dis-apply patents

The situation with developing countries is more complicated. A product free from patent may be produced locally or imported, while the government may issue a government use authorization or compulsory license for those under patent

The TRIPS Agreement permits granting of “compulsory” or “government use” licenses. Procedural requirements for government use licensing are normally less burdensome than for compulsory licenses

Grounds for compulsory license include: public interest, national or health emergency, to remedy anti-competitive prices, failure to produce domestically

A patent holder may offer to sell ARVs at a discount to a developing or least developed country, provided that there is a contractual commitment not to re-export the lower priced medicines.

The role of Procurement Authorities include: the evaluation of national IPRs situations, advocacy among government agencies to align priorities, and the monitoring of the patent and registration situation

Questions and Clarifications In the discussion session that followed the presentation, the following questions were asked and responses provided. Question: What are the consequences of India having to comply with TRIPS agreements by

January 2005?


Response: The provisions given were that by the 10th year, from 1995, patents will be filed in India, and they have to comply. The general counsel has waived however that India can export to other countries, depending on regional laws

Question: If patents for intellectual property are to pay for R & D, what is the rationale for

granting compulsory licenses? Response: These are safeguards against exploitation, as it is a non-exclusive license.

Sometimes, the R&Ds of the companies will change formulations, and present cases for new patents, sometimes for another 20 years. It is also important to note that even generics can be monopolistic, so it is preferable to have at least 5 generics.

Question: Can Kenya advise on how to obtain compulsory licenses? Response: It took a very long time. Compulsory licensing under the Office of Trade

Ministries is a very difficult provision. The example of France might be worth studying: France used authorization to ask for compulsory licenses fro other countries; this needed a change in French law at the EC. The TRIPS Counsel is asking countries to amend laws to allow for compulsory license.

Question: Does the NDRA allow acceptance of generic licensing before the patents expire? Response: The preliminary activities on generic products (quality assurance, clinical tests,

marketing etc) take a long time, sometimes up to 15 years, and can be commenced well ahead of registration

Question: Uganda has some products under patents, but is buying generics. How is this

happening without repercussions? Response: Uganda is classified as LDC, and buys generics from India. GSK attempted a

protest, but backed down when confronted by the president. Patent laws are being revised, and will contain TRIPS flexibilities

Question: Some countries are making efforts on TRIPS provisions, while some are not. What is the mechanism to use to advocate to countries to write up the few lines for TRIPS laws amendments?

Response: Advocacy is needed—to countries. WHO/AFRO, MSH, SADC, CRHCS etc should ensure this

Question: How can a country, such as Namibia, without patent laws, continue importing

from India? Response: India can produce patented products when asked to export to a country that can

import generic products. Namibia should not have any problem


Highlights of Group Work Presentations Group Presentation 1: Feedback on the PSM Plan

The progress, and challenges on the PSM Plan were stated by country. The new PSM template was announced to have a lot of useful changes, so should be now used for the PSM plan.

The importance of going on to the PSM implementation plan was emphasized

Group Presentation 2: Feedback on Issues around implementation of QA and procurement of non-health products

There are concerns on pre-qualifications: It appears that the WHO list is getting smaller

which limits competition. Furthermore, some countries have drugs that are not on the WHO list.

QA should not be limited to the regional level, but throughout the supply chain. Countries should prepare national guidelines on QA.

QC: Capacity (laboratories and Human Resources, need immediate and sustained funding WHO regional labs: there are delays in getting results from the labs referenced by GF There is a perennial non-availability of laboratory reference standards For the non-health sector goods, annual procurement is difficult due to lack of capacity.

There is also lack of storage and distribution capacity Units must be prepared to utilize goods, even when funds are available Procurement of vehicles: the responsibility of procurement may not be with the PR There is a plan to harmonize quality assurance systems in the SADEC region. This would

involve assessments of the existing facilities. The problems identified include accessing the acceptable reference standards for the analysis of ARVs without which reliance is made on manufacturers who provide the working standards for the finished products

Group Presentation 3: Feedback on needs for technical assistance for QA

Technical Assistance Required in NDRAs-for manpower, administration, registration

processes and systems TA is required for the conduct of cost benefit/effectiveness analysis of QA systems, and

to meet accreditation requirements/Good laboratory Practices to TA in post market surveillance, pre-distribution analysis, and pharmaco-vigilance TA is required for equipment specifications TA for countries to do pre-qualification of suppliers TA in objective evaluation of RFP for services and contract development

Discussions on Group Work Presentations:

• What is the cost-effectiveness of QC labs --to address needs for national labs or build up regional labs? WHO/AFRO classifies three different levels of labs. It is important to choose the level that can be sustained. All countries are encouraged to have at least a


level 1 lab because of the very strong dissuasive power of being able to identify if the active ingredient is there or not. In three years the percentage of products failing tests dropped drastically.

• We could collaborate with a teaching institution. For countries that do not have schools of pharmacy or any university that can help, the country should ask for TA to assess the capacities and estimate the costs for the upgrading or capacity building and include in the PSM plan. There is merit in performing the cost effectiveness analysis of investing in QC laboratories at the country level to see if it is worth it. The same applies to local manufacturing of ARVs.

The issue of whether the countries have laboratories with the technical capacity to

perform the QC tests. A strong advice for the countries to develop national guidelines on QA. Some countries reported that it takes very long time to get results from the regional Laboratory.

The issue of reference standards concerns all medicines. They can be obtained from the manufacturer. When you need the references standards, they have to be budgeted for and procured; they can now be used as reference to develop the working standards. There is a catalogue of WHO primary reference standards which can be made available on request

For non-health items, the countries have to go for annual procurement of such items.

Standardization of specifications for testing equipment required is vital for appropriate use and maintenance

Could WHO be of any assistance especially as the currency fluctuations affect the

procurement of products? Exchange rate appreciated or depreciated. What can be done? Phase two finds be borrowed to make up, by special request

Sometimes, as in Ethiopia, there are too many importers, and too many procurement times in a year. There is also rapid turn over of staff that have been trained. It is important that maintenance contracts attached with the procurement contracts. However, frequent ordering can be advantageous, provided that the estimates are well made, and you obtain quantity prices

Maintenance Contracts: for some lab equipment the contracts are drawn but not followed.

This should be dealt with when the problem arises. There is a component for general servicing, but when the equipment breaks down the recipient has to pay for the parts. This usually causes a problem with the government. A maintenance log is advisable, as well as training and re-training. Sometimes, the equipment may no longer be in the market; therefore, the parts may not be in stock. Therefore, countries should beware of tempting offers for equipment that is about to be phased out. One can also make a provision for the retention of 10% until the warrantee period expires. When tendering equipment, it is helpful to obtain a certificate of multiyear availability of parts at least for the economic life of the equipment


• There are far reaching consequences of the reliability of suppliers, and the clause on spare parts is not included in the contract. Many times, the cost of the spare parts is very high up to half the price of the machine itself

Additional issues or comments raised

• SADC would like to harmonize QA systems. If need to, countries can borrow from phase 2 funds to strengthen QSLs.

• No one has made Quality Assurance seem an emergency. Radical steps should be taken

to redress the situation • Funds are usually available to purchase non-health items, yet storage and distribution

capacities are usually inadequate, and the units unprepared to receive large volume items. Usually the PR is not authorized to buy vehicles, it may be assigned to another ministry.

• There are difficulties in sustaining and maintaining different equipments (e.g. CD4

machines). Even though maintenance contracts are attached to some of these goods, they are difficult to enforce.

Country Experiences on Maintenance of Equipment:

Country experiences vary: some countries e.g. Gambia have rotating staff, who retrains staff in use of equipment. In Kenya, for example, for CD4 machines in Mombasa, maintenance contracts are drawn but are not followed; technicians only come when there is a problem. They therefore developed a process for tracking maintenance visits for reminders to the staff. Initial training was by manufacturers, later the users were given advanced training to function also as trainers. In Nigeria, when equipment breaks down, contractor may say that user is responsible for parts, thus making maintenance more expensive than equipment.

In Uganda, MAP project gave CD4 machines, but the weak link is in supervision, as no one followed up to see if personnel received the training that was in the contract. In Ethiopia, there was lack of expertise to handle new machines; maintenance contracts are institutionalized, the same situation with copy and fax machines. A clause in the tender document ensures that there should be a local agent that can provide maintenance service.

The advice from UNICEF: is to look at what components affect the guarantee of equipment, and be aware that free installations may result in other costs being higher later. Be aware of receiving non-CE marked equipment, as such may be substandard (mandatory CE is to be enforced by 31st December 2004). UNDP advises of enquiring for a certificate of multi-year availability of parts.


Day Five: December 7, 2004 Synopsis: The day’s proceeding included three presentations on the subjects of Rational Medicines Use and Standard Operating Procedures. These were followed by Group work and subsequent plenary discussions. Thereafter, two other presentations were made: one on Management Information Systems, and the other by the Procurement and Supply Chain Management Consortium. Highlights of the Presentations 14. Rational Drug Use: Prescribing, Dispensing, Counseling and Adherence in ART Programs: Bannet Ndyanabangi (MSH/RPM Plus)

A case study of a patient sharing her ARVs was presented, which illustrated the need to investigate and take definite actions for rational drug use, and patient adherence

The specific relevance and significance of RDU to ART programs was highlighted, as a critical issue in the Pharmaceutical Management Cycle

Definitions of RDU, and descriptions of different types of irrational drug use (in diagnosis, prescribing, dispensing, and patient adherence) were made

Factors that influence the use of ARVs were identified Strategies and interventions to improve RDU in ART programs were discussed. These

include educational, managerial, economic and regulatory strategies. An intervention on a Drug Use problem (ARVs at Kenyatta National Hospital) was

discussed—situation analysis, actions taken, results and lessons learnt Issues on counseling for adherence problems, and the role of the dispenser in adherence

counseling were discussed, including the methods of measuring adherence Questions and Clarifications:

In the discussion session that followed the presentation, the following questions were asked and responses provided. Question: What plans are being put in place to assist the lower cadre in RDU? Responses: Since it has been recognized that in most pharmacies, it is the pharmacy assistants

that handle drugs, training materials have been developed in Mombassa, and are also being tested in Tanzania and Botswana. WHO and WB are also co-operating on some training materials

Question: How do we link the community ART to secondary levels of care? Response: Monitoring and evaluation will serve effectively to link certain aspects. Training

is also important


Question: Does co-payment of drugs ensure adherence and program ownership? Response: From Tanzania experience, some communities initiated co-sharing of payment.

However, in Uganda, there was evidence that use declined drastically even with marginal amounts charged. In Bangkok, experience shared pointed out defaults in ARV payments (i.e. access and RDU) when children were going back to school, and with funerals to attend to

Question: Who is in charge of pharmaco-vigilance—producer of drugs, or the country of

use? Response: The National Drug Information Authority has the primary responsibility of

pharmaco-vigilance, which incorporates safety and post-market quality issues. The country is responsible for the drugs it accepts and allows to circulate within it.

Question: Not all countries have the capacity for pharmaco-vigilance. This is easily seen in

the difficulties of surveillance for even well established diseases. The issues of cost also come in here. What is being done in countries?

Response: Nigeria included ADR in an ART survey it carried out in 2003. Mombassa is developing SOPs for ADRs, and prescribes the roles of the team that executes the ART in identifying ADRS. A scientific committee is also pushing for the reporting of the ADRs, which are being aggregated by the pharmacies. In Zimbabwe, a form is already in circulation. In Uganda, an attempt is being made to integrate the ADRs with those following vaccination.

15. Standard Operating Procedures for Pharmaceutical ART Services: Jedida Wachira (RPM Plus)

o The concept of a Standard Operating Procedure (SOP) was presented, to include: approved and detailed instructions, which cover all activities and provide in-depth description of what should be done, when, where, by whom, and how.

o The benefits of SOPs for Pharmaceutical ART services were outlined to include: ensuring quality and consistency of services, clarification of roles, a training tool, a means for delegation, and the provision of standards for monitoring and supervision

o The processes of developing ART SOPs (Mombassa experience) were described (SOP needs assessment, SOP development, and SOP implementation and maintenance, incorporating (M&E)

o Areas covered by Pharmaceutical SOPs are: Supply, Use, and Performance

16. Standard Operating Procedures for Laboratory ART Services: Ephantus Njagi

The components affecting the quality of routine laboratory work were identified to include: personnel, reagents, equipment/instruments, and other factors

Areas covered by laboratory SOPs include: The benefits of Laboratory ART SOP include: the provision of reliable results to the

doctor/patient, savings in time and money by the reduced number of repeated tests, early recognition of damage/expiry of reagents and instruments, objective basis for measuring


outcomes and staff performance, and improved reputation of the lab services, benefiting both the user and provider

In terms of the PSM, laboratory SOPs contribute to fast and reliable lab results for clinical evidence based decision making, including ARV initiation, ARV selection, monitoring of ARV toxicity and efficacy, and appropriate changing of therapy

Guidelines to sustaining the use of SOPs were suggested (regular updating, development of new SOPs as needed, incorporation into on-going training, sharing of tools, and adaptation for other service components

Questions and Clarifications:

In the discussion session that followed the presentation, the following questions were asked and responses provided. Question: Were the SOPs presented adapted from a previous version? Are they available for

sharing? Response: There were no SOPs, but forms that were already being utilized were used. The

SOPS are available, and included in the CD ROM pf participants (SOPS for Pharmaceutical, and for lab)

Question: Is the Global Fund ready to sponsor countries to develop their SOPs? Response: Since this can be classified as Operations Research, GF should be able to pay Question: How fast can an STG be developed? Can we have drafts so we do not start from

scratch? Response: It took longer for the first draft to be developed and revised but later adapting and

testing can be completed in about a month. The project is considering generic drafts that can be adapted by countries to suit their needs

Question: What is the reporting rate? Is it acceptable? What is the coverage of the pilot program? Response: The pilot SOP in Mombassa is in only 1 city; rolling up a national programme

will be a huge challenge. However, the SOPs are being circulated. In Zimbabwe, there is obvious underreporting

Additional Comments:

• Community interaction needs to be strongly emphasized as a strong link in RDU. It is important however to weigh the pros and cons of family representation after diagnosis.

• In light of the 3 by 5, capacity building needs to be strongly emphasized in the PSM plan: who is going to distribute these drugs at community level. Therefore, there should be strong emphasis on getting the SOPs down to the operational levels of care so that functions can be delegated.

• One of the biggest challenges in comprehensive training is the attrition rate of the trainees. It is also important to involve the research institutions

• RDU also depends to a great extent on uninterrupted supply of drugs for OIs


• There is need to have a patient information system such patients can quickly identify differences in their drugs and alert someone in cases of mistakes

• It is important to see the patient defaults as fuelling the spread of HIV, just as in TB • As in Nigeria, even when ARV cost is subsidized, without subsidizing the costs of

laboratory procedures, such as CD4 count, there may be no true RDU in the ART; this needs major policy considerations

• Apart form co-financing for the drugs, logistics financing is a vital step that must be considered, as some CBOs default to collect or distribute drugs because of logistic needs

• The experience worldwide has shown significant underreporting. We should try not to duplicate systems for tracing ADRs. Where the existing systems are slow, we should still integrate into them, but trace closely, and motivate workers so as to scale up their adherence to reporting by incentives and feedbacks.

• Training programmes for prescribes on ADRs should not be forgotten

17. Management Information Systems: Sergio Valdini (UNDP, Liberia)

• The MIS model was depicted as a customized and user-friendly solution, which can alter the exiting solution with no or minimal system change, with short updating time

• The system supports the M&E unit inn terms of reporting needs, efficient tracking systems, and graphical presentation of information for Strategic Management

• The technology uses a three-tier architecture with MS SQL SERVER 2000, ASP, and HTML

• The advantages offered were said to include: speed of data transfer, fast and safe security network environment, a logically related database components, integration of multiple database, and ability to export data in server to all major formats. Training for the MIS is simple and short-term; remote assistance and technical assistance is also provided through e-mail or messengers

Questions and Clarifications: In the discussion session that followed the presentation, the following questions were asked and responses provided. Question: Has the MIS system (presented by UNDP Liberia) been able to handle PSM

issues? Response: It can handle whatever is programmed into the system. The system has been used

for product management and distribution


18. Procurement and Supply Chain Management Consortium: Addressing

Implementation and Capacity Building simultaneously: Crown Agents, GTZ and JSI Logistic Services

Four partners make up the consortium: KEMSA, Crown Agents, GTZ and JSI Logistics

Services. It is a partnership designed to use external expertise, while at the same time building capacity within KEMSA, and transferring skills

The goal of the consortium is a secure and sustainable supply chain that ensures maximum access to essential commodities of assured quality at the minimum cost, and in the shortest possible time

The methodology of the consortium is a three-phase approach consisting of: Phase 1: (Immediate Response), Phase 2: (Intensive Capacity Building), & Phase 3: (Sustainable Delivery by KEMSA)

The critical issues are the accurate definition of commodity needs, establishing secure supply chains, coordination with other initiatives in KEMSA, overcoming capacity constraints, accelerating procurement procedures, and working within existing government infrastructure and regulations

Achievements to date were outlined-tenders issued closed and under evaluation for ARVs, HIV Test kits and Malaria Bed nets, while others have been prepared for laboratory supplies, medical equipment, bed nets and pharmaceuticals

Questions and Clarifications: In the discussion session that followed the presentation, the following questions were asked and responses provided. Question: Does the consortium buy directly from manufacturers? Response: They open tenders on every occasion—it depends on bids, and who wins. Question: Does the consortium have different stores for goods by different bids? Response: There is a module for regional storage, and distribution. As it stands, the donors

are still fiercely protective of their goods and commodities Question: There is little information available on CD4 machines and reference materials. Response: This is a highly specialized question needing special attention. However, it is

important to note that new technologies are in the pipeline, so countries should not over-invest in CD4 machines now.

Question: What are the expectations for the sustainability of this arrangement? Response: KEMSA is a client, as well as a partner in this arrangement being tired out.

However, there are clear capacity building and exit components. Question: What are the cost implications of running the procurement/supplies with this

consortium?


Response: The results so far show that savings are more than 30% from previous records. The procurement fees are about 2%, while TA, and capacity building are paid for at international rate.

Highlights of the Group Work Presentations: Group Presentation 1: Feedback on the PSM Plan

• Paul Lalvani (GF) announced that 95% of the materials in the PSM plans have been approved

• 20 copies of the Template for the PSM plans that were distributed have returned with comments, which will lead to its review. 1 copy each of the revised template will be handed over to each country, and partner to still check any aspect needing review or clarification

Comments on PSM Planning

• One of the major challenges in PSM planning is the 48% of funding allocated by GF to private sector participation. The GF is being criticized for not inadequate involvement of the private sector, while countries are complaining of the exact opposite. Causes of conflict need to be identified, and ways of resolution them developed, for example, monitoring the private sector can be set under private sector funds. It is important to reflect that the private sector has done a lot in the realization of fund raising goals, and also have a large part to play in sourcing and distributing products, and treatment, as well as capacity building (training, regulation and monitoring).

• There is the additional challenge that many faith-based organizations do not include

condom-promotion as part of their intervention, and furthermore lack the ability to handle bigger financial resources. The private sector must first be accredited, and then they are monitored afterwards. There is need to strengthen the monitoring aspect of the program We may note that products (ARVs) may be free, but we may still allow service fees in the private sector

• PEPFAR funds (and others) have the effect of generating new opportunistic NGOs. There is need to institute more stringent registration processes for NGOs. It is important to follow through with this issue to avoid becoming a grant monitoring organization. There is a palpable risk of product diversions, non-taxable expenses, and promotion of personal agenda in private for profit organizations; however, there must be a system to bring them on board. In the Philippines, there is already a template for monitoring NGOs.

• It was raised that the GF focuses not only on the output indicators, but also the process indicators, such as the time lag between receipt of funds and when goods reach the CMS, and stock outs—frequency and duration. WB and GF should agree on indicators. However, it was also emphasized that the GF is mainly a fund raising and granting agency


The issue of brain drain was discussed with the conclusion that it is good to develop motivation for staff. It is also imperative to develop Team Work of all involved in ART

Group Presentation 2: Feedback on Implementation Issues To Be Covered • Previously discussed issues were identified as:

o Paedriatric HIV Care and Support o Coordination (multi donor funding, and how to mix funding streams) o Country programming for multiple diseases o Sources of products o Supplier –related matters (long lead times, listing and de-listing of products,

changes in country drug forecasting, packaging sizes/pack sizes). The role of WHO/AMDS

• Issues yet to be discussed were identified as: o Monitoring of ADR and drug resistance o Allocating and matching patients with different sources of products o Treatment related matters (levels of care, where to treat, Human Resource crisis in

health care, roles of professionals) o Public/Private sector collaboration on ART o MIS (who collects the data, how to analyze, feedback etc) o The Three Ones o How to start after procurement plan has been approved o QA and QC o Resources-related matters

Group Presentation 3: Feedback on Implementation of RDU The group work considered the following issues:

o Availability of Standard Treatment Guidelines (STGs) o Revision of STGs o Whether STGs are WHO compliant o Trainings of prescribers, dispensers and counselors on STGs o Monitoring of ARV usage o Strategies put in place to monitor RDUs o Medication Use Counseling o Pharmaco-vigilance o Drug use Survey o Patient Interception—drug use discussions

The conclusions of country experiences shared are that:

• Monitoring of ARV usage is not strong in many countries • Accreditation of prescribers is on in ZW, but is likely to suffer resistance from clinicians • The arguments of free drugs or cost sharing are inconclusive between countries • There are identified challenges in enforcing STGs on prescribers that do not comply


• Among strategies put in place to enhance RDU are: Fixed Dose Combinations (ZW), Patient packs for a month’s supply as well as medication use counseling (Kenya). In Ghana, patients are requires to bring back the empty containers so they do not go back into circulation. In addition, drugs are to be returned in cases of patient changing regimen, or death

• Generally, structures for pharmaco- vigilance are limited, and weak even when they exist There was a report that there is imminent threat to RDU in some countries because of the lack of commitment by government to help the regulatory bodies. There is real fear that ARVs will soon join the unregulated drugs in the market. The importance of regulation, training and advocacy for effective policy was emphasized, and the government needs to put on board a comprehensive array of stakeholders, including professionals, police etc. since they are the means of halting the threat.

After the session for the day was closed, the participating organizations met to discuss their observations and assessment of the day, as well as to plan and strategize for the following day’s session.


Day Six: December 8, 2004 Synopsis: The day’s proceeding included two presentations on the subjects of HIV/AIDS related Management Capacity and Financing, and Donor HIV/AIDS Commodities Tracking Tool. The new Global Fund template was presented and discussed (format included in the annexes); this was followed by the Workshop Evaluation (format included in annexes) and closing discussions on the latest version of the Global Fund template A presentation summarizing the TA requests was made, after which the outcomes of the PSM workshop (Tangible Outputs) were presented. Closing remarks were subsequently made, and a representative of the participants ended the workshop with acknowledgements. Highlights of the Presentations 19 HIV/AIDS Related Procurement: Management Capacity and Financing: Nadeem Mohammed (World Bank)

Key steps in procurement were revisited with accentuation of needed emphasis: (for product selection, forecasting, procurement, warehousing, inventory management, transportation, and serving clients

Causes of delays were outlined for each step, and include lack of clinical protocols, guidelines, policies, data (on consumption patterns or stock levels), poor specifications, incomplete projections, unclear procedures, breaks in information to storage staff of impending procurement, volume deficiencies, lack of essential computerizations and stock cards, unclear transport procedures, and lack of availability of commodities, and insufficient budget allocations

Suggested interventions were outlined, which include the development of protocols using WHO guidelines, development of forecasts, and installation of LMIS, the use of WHO pre-qualified suppliers, meeting warehousing needs, outlining inventory management procedures, developing transport management plans, and monitoring of stock outs at service delivery points

Management weaknesses were identified (personnel, logistics, tools and manuals, monitoring supervision and strengthening) concluding with the need to create effective Team Work

It is important to share technical specification, documents and research between countries Some Capacity building programmes on ARV and Related supplies (PSMP) for 2005

were announced, at regional levels, and a 2-phase national level. Then PSMPs are global training events financed by The Bank, Dutch, Canadians, WHO (TA) UNAIDS (for 2005)


An estimated US$2.7 billion is to be committed to SSA by the World Bank, Global Fund and Bilaterals (excluding PEPFAR). The AVAILABLE FINANCING FROM ALL SOURCES IS TO BE COORDINATED

Policies to maintain funding for commodities as well as logistics are to be established Questions and Clarifications:

In the discussion session that followed the presentation, the following questions were asked and responses provided. Question: At what level do we bring PEPFAR inputs into the main funding stream? Response: The US government has not been able to take part in the basket funding. The need

to collaborate must be emphasized, especially when it becomes obvious that other bilaterals are also funding heavily, and that they are not always the major players e.g. in Mozambique. The major assessments of how money flows, absorption, amount gotten to target recipients, donor predictability are all major management issues. The country also has to be focused on their needs to direct PEPFAR to needed projects. e.g. in South Africa, World Banks funds were requested for PMTCT as top priority. The World Bank is sharing information with PEPFAR by on how to strategize the project. A meeting is on immediate pipeline for an overall review of ART in Africa.

Question: Global Fund is insisting that most of the funds should go to private sector, i.e. the

emphasis is on NGOs and FBOs. Therefore, people are leaving the public sector to go into the Global Fund private sector projects. Can donors top up salaries of civil servants to prevent brain drain within and outside of the country? In addition, creating dedicated full time staff for HIV/AIDS is a very challenging issue for developing countries to implement

Response: The donors are working with the government, and some are considering temporary contracts, which will also build capacity. Global Fund has employees only in Geneva, and is not into creating parallel systems, which destroys a lot of things and are not sustainable. The GF allows the hiring of consultants.

Question: In some countries, for example Angola, it is difficult to see a body dealing with

logistics. The neglect of this vital aspect has been shown in difficulties of taking goods to the village

Response: It is important to use any available method to solve the issue of logistics Additional Comments:

The AMDS (AIDS Medicines and Diagnostic Services) was introduced as a specialized UN organization by Jos Perriens

There needs to be a level playing field for the partners. The WHO secretariat does not take position with any partner. For Global Fund, the issues are what is the quality, and what is the total cost? It is important that the countries take the lead. There is


opportunity to define the Terms of Reference and then they can be taken forward. If there are common requests across many lists, they can be pooled together.

It appears that PEPFAR is targeting NGOs and FBOs. But the truth is that as they provide about 40% or more of services, they should be seen as partners in the health care system, rather than just implementers.

Procurement of non-health sector goods is possible without stringent policies; the collection of data poses a definite challenge.

For annexes 1a and 1b, it is good to have separate parts for health sector and non-health sector goods

Supplies of Glaxo products will commence by March—any country that may have a stock out crisis before then should place an early alert to UNICEF.

20. HIV/AIDS Commodities Tracking Tool: Laila Akhilagi (RPM Plus)

The background of the commodities tracing tool was described, as originating from a July

2003 meeting of MSH, Global Fund, World Bank and the U.S. Government which had the objectives of identifying HIV/AIDS commodities management issues of concern to key global partners

The need for information sharing was highlighted, in terms of multi-donor targeting and rapidly expanding and changing knowledge base

The strategy for building the CTT was described (web-based information, password protected, centrally maintained by MSH, and accessible to all stakeholders in disparate locations)

It is to commence with data for commodities provided by PEPFAR and other US funded programmes, and expand to include HIV/AIDS initiatives funded by other donors, as well as initiatives focusing on other health commodities

Questions and Clarifications: In the discussion session that followed the presentation, the following question was asked and response provided. Question: The real problem with commodities tracking is to know what goods are available

in the stores. Does this software (Commodities Tracking Tools) present solutions? Response: We need to clarify what information we are actually looking for (e.g. on ARVs,

diagnostics, etc) before the use can be streamlined. In addition, stakeholders have to be coordinated.


21. The Global Fund Template (newest version): Paul Lalvani (Global Fund)

• The new Global Fund Template was presented by Mr. Lalvani, as composted from the

several comments and deficiencies noted in the earlier versions Questions and Clarifications: In the discussion session that followed the presentation, the following questions were asked and responses provided.

Question: Is it every time there is a new proposal that the all the contents will be re-written? Response: The institutional contents do not have to change, but the front page and relevant

annexes will, as they will be updates reflecting the progress of the last proposal. In Rounds 1 and 2, there were no templates used, showing the flexibility of the funding mechanism. However, the templates have helped to direct the planning process, and solve problems experienced for the 1st and 2nd Round Planning.

Question: One of the objectives of the fund is to strengthen countries. The LFAs do PSM

reviews, should they not also have reviews made of the progress throughout the years to produce a systematic format of achievements?

Response: Much experience has been gained by doing, and running these systems is still a challenge Question: Sometimes, it still takes a long time before funds are accessed; should details for

implementation not be developed before the approval of proposals? Response: This is a provision for adaptation of the proposal, and information on changes will

help to accelerate the remaining processes 22. TA Requests: Tomas Schick (UNAIDS)

9 countries out of the 13 present were reported to have responded to the TA request format

TA Requests (by number of requests) 3 Intellectual Property Rights (Patents) 5 Forecasting 2 Procurement (including pricing) 5 Supply Chain Management (Storage, LMIS, Inventory) 4 Quality Assurance (including NDRA, Registration, QA, QC, Pre-qualification) 1 Procurement of non-health products 4 Rational Drug Use (STGs, Resistance, Adherence, ADRs) 2 Comprehensive TA and Capacity Building Plan development

Most of the requests (20) did not specify the partner for the TA; however, a few (5) specified some UN agencies: WHO, UNAIDS, as well as MSH and JSI

The financing source for most TA requests (18) was the GF grant, while some sources (6) were the UN agencies, PEPFAR, USAID and SWAP). By number of countries, 8


depended on the GF grant, while other funds identified for countries included PEPFAR (2), USAID (1).

Out of the TA requests, 5 were definitive (no further consultations needed), while 20 requests still needed further consultations, with expected decision dates given)

Out of the 9 countries that responded, 2 had definitive TA requests, while 7 countries still needed further consultations on needed TAS, with expected decision dates given).

23. Outcomes of the Workshop: Paul Lalvani (Global Fund)

The stages in the PSM Plan are six fold: (1).PSM Plan in progress; (2) PSM Plan

Completed; (3) PSM Plan Approved; (4) Country Authorized for procurement; (5) Funds in country

for procurement; (6) Country has conducted procurement.

• At the beginning of the PSM workshop:

o 6 countries were in Stage 1: {Angola, Ghana (Rd 1, Phase 2), Ethiopia (Rd 2,

o Phase 2, Round 4), Uganda (Round 3), o Tanzania (Round 4), and Sierra Leone} o 1 country was in Stage 2: {Liberia} o 1 country was in Stage 3: {Zimbabwe}-not signed o 3 countries were in Stage 4: {Lesotho, Namibia, Tanzania} o No country was in Stage 5: o 5 countries were in Stage 6: {Uganda (Rd 1), Kenya, Malawi, o Ghana (Rd 1), Ethiopia (Rd 2, Phase 1)

• By the end of the PSM Workshop:

o 1 country was in Stage 1: {Angola} o 6 countries were in Stage 2: {Liberia, Ghana (Rd 2, Phase 2), Ethiopia

(Rd 4) o Uganda (Rd 3), Tanzania (Rd 4), Sierra Leone o 1 country was in Stage 3: Zimbabwe -not signed o (Countries formerly is Stages 4 and 6, retained status quo on those

Rounds/Phases)

• The main outcomes of the workshop can thus be seen in the progress made by 5 countries in advancing from Phase 1 to Phase 2 (i.e. from PSM Plan in progress to completion of PSM Plan).


24 Closing Remarks: Dr. Vincent Habiyambere (WHO/HQ) with inputs from Dr. Jos Perriens (WHO) and Dr. Patrick Osewe (World Bank)

Of about 40 million PLWHAs, about 6 million are projected to need ARVs; the 3 by 5 attempts to treat 3 million by end of 2005

There was a great need for Technical assistance for moving forward the PSM plans, hence the workshop. The greatest challenge that emerged is that of procurement

The outcome of the workshop is very tangible—this is the particular objective of the AMDS

The choice of the participants was seen as very appropriate, and experiences shared especially by those implementing has made the workshop an incredible learning process for every one

Appreciation was expressed to all the agencies that contributed to the success of the workshop

Compliments were given to all the country participants present for their hard work Gratitude was expressed to the Kenyan government, the Kenya WHO office, and all

those who facilitated the meetings, including the hotel management Special appreciation were made to Jos Perriens (AMDS) who conceived the workshop in

Bangkok, and Paul Lalvani for facilitating the process of “unlocking” the Global Funds for absorption by the countries

The need to take exceptional measures to actualize the goal of mitigation the effects of HIV/AIDS was re-echoed

In Concluding, the speakers reiterated that:

There are ∼6,000 deaths per day in SSA due to AIDS, and ∼8,000 new infections daily.

The challenge is to change from bureaucratic mentalities and be encouraged to use exceptional and revolutionary measures to halt the pandemic. For example, taxicabs are used to transport drugs in South Africa

It is necessary to keep the objectives of the Three Ones (one National framework, one institution, one M & E system)

It is necessary to use exceptional methods, even when they are expensive, to contract out routine and mechanical tasks, and adapt quickly. Automation is needed urgently to manage inventory

There is need to promote coordinated efforts in the area of HIV/AIDS commodities management system strengthening, and establish on-going processes and mechanisms for consultation, coordination and information sharing.


Day Seven: December 9, 2004 SITE VISITS BY PARTICIPANTS AND FACILITATORS One of the following:

• MEDS • KEMSA


ANNEXES

Annex 1 Time table for Daily Proceedings DAY 1: Thursday 2 December 2004 SESSION I: 08:30 – 18:30 08:30 – 10:00 Registration/Administrative / Housekeeping 10:00 – 10:30 Opening ceremony 10:30 – 10:45 Tea/Coffee break 10:45 – 11:00 Objectives and expected outputs of the workshop: J. Perriëns Proceedings of the whole workshop: V. Habiyambere 11:00 – 12:30 The PSM plan: Key principles: B.E. Seki

Plenary discussions for clarification 12:30 – 13:30 LUNCH 13:30 – 15:00 Product selection Plenary: E. Capuno HIV Medicines selection: experience from Uganda: J. Serutoke

Plenary discussions for clarification 15:00 – 16:15 Working Group session 16:15 – 16:30 Tea/Coffee break 16:30 – 17:30 Plenary 17:30 – 18:30 Partner organisations meeting


DAY 2: Friday 3 December 2004 SESSION II: 08:30 – 17:30 08:30 – 08:40 Administrative / Housekeeping 08:40 – 09:00 Overview of the PSM Plan: P. Lalvani 09:00 – 09:10 Plenary: Q & A 09:10 – 09:30 Forecasting : Considerations for preparing a PSM plan: H. Moller 09:30 – 10.00 Patents: National and international laws: P. Osewe 10:00 – 10:30 Plenary: Clarification, introduction to group work 10:30 – 10:45 Tea/Coffee break 10:45 – 11:45 GROUP WORK 11:45 – 12:30 Plenary feedback ( 10 min feedback, 5 min discussion each question ) group 2 to give feedback on issues to cover in PSM plan group 3 to give feedback on issues around implementation group 4 to give feedback on needs for TA Rest to fill in the PSM plan 12:30 – 13:30 LUNCH 13:30 – 14:00 Plenary: Introduction to the development of the PSM plan: P. Lalvani 14:00 – 16:15 Country specific work on PSM plans / implementation plans 16:15 – 16:30 Tea/Coffee break 16:30 – 17:30 Plenary 17:30 – 18:00 Quantimed (MSH quantification software) demonstration: L. Akhlaghi 18:00 – 18:30 Partner organisations meeting


DAY 3: Saturday 4 December 2004 SESSION III: 08:30 – 17:30 08:30 – 09:00 Administrative / Housekeeping 09:00 – 10:30 Logistic cycle: A. Bahati Logistic management information system (LMIS): J. Waweru Inventory Control: Walter Proper Plenary: Clarification, introduction to group work 10:30 – 10:45 Tea/Coffee break 10:45 – 11:45 GROUP WORK 11:45 – 12:30 Plenary feedback ( 10 min feedback, 5 min discussion each question ) group 2 to give feedback on issues to cover in PSM plan group 3 to give feedback on issues around implementation group 4 to give feedback on needs for TA Rest to fill in the PSM plan 12:30 – 13:30 LUNCH 13:30 – 14:00 Plenary: Introduction to the development of the PSM plan: P. Lalvani 14:00 – 16:15 Country specific work on PSM plans / implementation plans 16:15 – 16:30 Tea/Coffee break 16:30 – 17:30 Plenary 17:30 – 18:30 Partner organisations meeting


DAY 4: Monday 6 December 2004 SESSION IV: 08:30 – 18:30 08:30 – 08:40 Administrative / Housekeeping 08:40 – 09:00 Quality Assurance: T. M. Lapnet 09:00 – 09:30 Procurement of non- health products : E. Capuno 09:30 – 10.30 Plenary: Clarification, introduction to group work 10:30 – 10:45 Tea/Coffee break 10:45 – 11:45 GROUP WORK 11:45 – 12:30 Plenary feedback ( 10 min feedback, 5 min discussion each question ) group 2 to give feedback on issues to cover in PSM plan group 3 to give feedback on issues around implementation group 4 to give feedback on needs for TA Rest to fill in the PSM plan 12:30 – 13:30 LUNCH 13:30 – 14:30 Practical implications of utilising flexibilities in the TRIPS agreement:

J. Perriëns and P. Osewe Plenary Discussion

14:30 – 16:15 Country specific work on PSM plans / implementation plans 16:15 – 16:30 Tea/Coffee break 16:30 – 17:30 Plenary 17:30 – 18:30 Partner organisations meeting


DAY 5: Tuesday 7 December 2004 SESSION V: 08:30 – 18:30 08:30 – 08:40 Administrative / Housekeeping 08:40 – 08:55 Rational Drug Use ( Prescribing, Dispensing, Counselling, Adherence) Bannet Ndyanabangi 08:55 – 09:10 SOP’s for Pharmaceutical ART Services: Jedida Wachira 09:10 – 09.25 SOP’s for Laboratory ART Services: Ephantus Njagi 09:25 – 10:00 Plenary: questions for clarification 10.00 – 10:30 Introduction to group work 10:30 – 10:45 Tea/Coffee break 10:45 – 11:45 GROUP WORK 11:45 – 12:30 Plenary feedback ( 10 min feedback, 5 min discussion each question ) group 3 to give feedback on issues to cover in PSM plan group 4 to give feedback on issues around implementation group 1 to give feedback on needs for TA Rest to fill in the PSM plan 12:30 – 13:30 LUNCH 13:30 – 14:00 Plenary: Introduction to development of the PSM plan 14:00 – 16:15 Country specific work on PSM plans / implementation plans 16:15 – 16:30 Tea/Coffee break 16:30 – 17:30 Plenary 17:30 – 17:45 MIS: Experience of UNDP Liberia 17:45 – 18:00 Procurement planning: Experience of Crown Agents/GTZ/JSI/KEMSA

Consortium 18:00 – 18:30 Partner organisations meeting


DAY 6: Wednesday 8 December 2004 Session VI: 08.30-15:30 08.30-9.00 Administrative/Housekeeping 9.00-10.00 HIV/AIDS Related Procurement: Management Capacity and Financing:

Nadeem Mohammed (World Bank) 10.00-10.30 HIV/AIDS Commodities Tracking Tool: Laila Akhlagi (RPM Plus) 10.30-11.00 Tea/Coffee Break 11.00-11.30 Workshop Evaluation: Participants and Facilitators 11.30-12.00 PSM Workshop Evaluation: 12.00-12.30 The Global Fund Template (newest version): Paul Lalvani (Global Fund) 12.30-1.30 LUNCH 1.30-2.30 TA Requests: Thomas Schick (UNAIDS) 2.30-3.30 Wrap Up 1: Outcomes of the Workshop (Paul Lalvani (Global Fund) Wrap-Up 2: Closing Remarks (Dr. Vincent Habiyambere (WHO/HQ)

with inputs from: Dr. Jos Perriens (WHO) & Dr. Patrick Osewe (World Bank)

3.30 Meeting of Partner Organizations DAY 7: Thursday 9 December 2004 SESSION VII: 08:30 – 12:30 08:30 – 12:30 Site visit to MEDS and to KEMSA


Annex 2 List of Participants


Proceedings of the PSM Workshop - Nairobi 2-9 Dec. 2004The impacts of Quality Assurance on the PSM...

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Transcript of Proceedings of the PSM Workshop - Nairobi 2-9 Dec. 2004The impacts of Quality Assurance on the PSM...